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Depression and ART Adherence in HIV+ Latinos

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ClinicalTrials.gov Identifier: NCT01411839
Recruitment Status : Unknown
Verified August 2011 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : August 24, 2011
National Institute of Mental Health (NIMH)
University of Texas
Information provided by:
University of Washington

Brief Summary:
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.

Condition or disease Intervention/treatment
Depressive Symptoms HIV Infections Behavioral: Cognitive-Behavioral Therapy AD

Detailed Description:
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version. Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
Study Start Date : July 2008
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy (CBT-AD)
CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.
Behavioral: Cognitive-Behavioral Therapy AD
Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
Other Name: CBT-AD
No Intervention: Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Changes in depression ratings at two time points: From baseline to 6 and 9 month follow-up ]
    The MADRS is a 10-item clinician administered scripted rating scale of depressive symptoms. The scale was develop to capture current depressive symptoms within the past seven days. The areas covered include: apparant and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Both control and treatment conditions are interviewed with the MADRS at baseline and at 6 and 9 month follow-ups for any changes.

Secondary Outcome Measures :
  1. Self-Report Adherence [ Time Frame: Changes in self-reported adherence from baseline through 9 months ]
    From the Visual Analogue Scale or brief items

  2. MedSignals Electronic Pill-box for Adherence [ Time Frame: Changes in adherence at two-time points: from baseline to 6 and 9 month follow-up ]
    The MedSignals electronic pill-box is a elecontric storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants of their dosing regimen. The pill-box stores adherence information (time, number of openings). In the control condition, the pill-box does not alarm participants. The pill-box serves as a storage bin for the control condition and stores adherence data. All data is then uploaded onto an online database for investigators.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site);
  • 18 years of age or older;
  • Latino (i.e., self-identified as being of Mexican heritage);
  • English- or Spanish-speaking
  • capable of giving informed consent;
  • currently on a prescribed antiretroviral regimen;
  • suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks);
  • exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.

Exclusion Criteria:

  • actively psychotic or so cognitively impaired that they cannot participate,
  • so physically ill as to be unable to come to the clinic to participate in the intervention, OR
  • Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days.
  • Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom
  • have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411839

United States, Texas
Centro de Salud Familiar La Fe CARE Center
El Paso, Texas, United States, 79925
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
University of Texas
Principal Investigator: Jane M Simoni, Ph.D. University of Washington

Responsible Party: Jane M. Simoni, Ph.D., University of Washington
ClinicalTrials.gov Identifier: NCT01411839     History of Changes
Other Study ID Numbers: 35279-C
R34MH084674 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by University of Washington:
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:
HIV Infections
Behavioral Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases